We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.

Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily

Drug: Efavirenz, lamivudine, and tenofovir

Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily

Other Name: Atripla, Epivir and Viread

Experimental: Standard Treatment Plus Enfuvirtide

Efavirenz 600mg once daily, Lamivudine 300mg once daily, Tenofovir 300mg once daily and enfuvirtide 90mg subcutaneously twice a day until the viral load is less than 50copies for 2 consecutive visits or 12 weeks (whichever comes first).

Drug: Enfuvirtide

subcutaneously twice a day

Other Name: Fuzeon (T-20)

Drug: Efavirenz, lamivudine, and tenofovir

Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily

Other Name: Atripla, Epivir and Viread

Detailed Description:

This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.

All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first).

Volunteers must be willing and able to provide written informed consent to participate in the study.

Available for at least 48 weeks of follow-up.

Exclusion Criteria:

Volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite ART.

Volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with patient's ability to comply with protocol requirements.

Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)

Patients with malabsorption or severe chronic diarrhea for more than 30 days.

Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results.

Pregnancy or breastfeeding

In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence

Patient who is currently receiving an experimental medication.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344760

Locations

United States, Maryland

University of Maryland, Institute of Human Virology

Baltimore, Maryland, United States, 21201

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Ronald B Reisler, MD, MPH

University of Maryland, School of Medicine, Department of Infectious Disease